Ambu AuraGain versus LMA Supreme Second Seal: oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001290684
• Date of registration: 10/12/2014
• Prospective Registration: No
• Primary sponsor: Department of Anaesthesiology, Universiti Malaya
• Public title: Ambu AuraGain versus LMA Supreme Second Seal: oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients
• Scientific title: Ambu AuraGain versus LMA Supreme Second Seal: comparing oropharyngeal leak pressures and gastric drain functionality in spontaneously breathing patients under general anaesthesia
• Date of first enrolment: 11/11/2014
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12614001290684.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Malaysia

Contacts

• Name: Dr Ina Ismiarti Shariffuddin

• Name: Dr Ina Ismiarti Shariffuddin

Key inclusion & exclusion criteria

Inclusion criteria: Adult surgical patients above 18 years of age, undergoing surgery under general anaesthesia (appropriate to be done with a supraglottic airway device)
Exclusion criteria: ASA IV;
morbidly obese BMI > 40kg/m2;
high risk or regurgitation/aspiration e.g.: symptomatic gastro-oesophageal reflux, hiatus hernia;
respiratory tract pathology e.g.: preoperative sore throat


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Anaesthetics

Supraglottic device use in spontaneously breathing patients under general anaesthesia;
Supraglottic device use in spontaneously breathing patients under general anaesthesia

Intervention(s)

Insertion of Ambu Auragain supraglottic device by an experienced anaesthesiologist (>10 year working experience).

The Ambu Auragain differs from the LMA Supreme (control device) in which it has the added feature of intubation capability.
After the placement of the Ambu Auragain, it can be used as a conduit for direct endotracheal intubation assisted by a flexible scope.


Patient is not premedicated. He/she will be positioned supine, and pre-oxygenated for 3 minutes.
Standardised induction of anaesthesia with intravenous fentanyl 1-2 mcg/kg and propofol 2-3mg/kg.
Ambu Auragain will be inserted when the patient's jaw is sufficiently slack.
The duration of an insertion attempt is no longer than 120 seconds.
The appearance of the first square end-tidal CO2 trace denotes successful establishment of effective ventilation.
Otherwise, the device will be completely removed for another insertion attempt. (up to 3 attempts allowed)

Once in place, the Ambu Auragain will be secured with surgical tape.
A prelubricated 14 French gauge gastric tube will then be inserted into the gastric drain outlet, and ease & time taken for insertion will be assessed.
Gastric decompression will be done and total amount of gastric fluid aspirated to be recorded.

Oropharyngeal leak pressure will be measured after closing the adjustable pressure limiting valve with a fresh gas flow of 3 L/min, noting the airway pressure at equilibrium or when there is audible air leak from the throat.
Maximum pressure allowed is 40 cm H2O.

The patient's heart rate and blood pressure will be recorded every minute for the first 5 minutes from induction of anaesthesia.
Anaesthesia will be maintained with sevoflurane 1-2 MAC.

Upon end of the surger

Primary Outcome(s)

Measurement of oropharyngeal leak pressure (in cm H2O) of the satisfactorily placed supraglottic airway device, using a handheld aneroid manometer (Portex Pressure Gauge)[After insertion of supraglottic airway device]

Ease of insertion of gastric tube through the supraglottic airway device's gastric drain outlet.
Ease of insertion will be graded on a scale of 1 (easy), 2 (acceptable), 3 (difficult), and recorded in the data collection sheet.
[After insertion of supraglottic airway device]

Secondary Outcome(s)

Ease of supraglottic airway device insertion and number of attempts required.
Ease of insertion will be graded on a scale of 1 (easy), 2 (acceptable), 3 (difficult), and recorded in the data collection sheet.[During insertion of supraglottic airway device]

Manouvres required to optimise ventilation after supraglottic airway device insertion:
-Head/neck position adjustment
-Change of depth of device insertion
-Application of jaw lift
-Change of device size
-Reinsertion of device[After insertion of supraglottic airway device]

Haemodynamic response to insertion of supraglottic airway device
(Systolic/diastolic/mean arterial blood pressure, heart rate)
-measured using automatic sphyngomanometer and ECG[From time of supraglottic airway device insertion, up to 5 minutes post insertion]

Complications of supraglottic airway device insertion, will be assessed by an unblinded independent observer who is not involved in this study.
Any complications noted will be recorded on the data collection sheet.
(Desaturation SpO2 < 95%, gross regurgitation/aspiration, tongue trauma, lip injury, difficulty in ventilation, bronchospasm, mucosal injury, post operative sore throat, dysphonia, dysphagia, dental injury)[From time of supraglottic airway device insertion up to 45 minutes after supraglottic device removal]

Secondary ID(s)

nil

Source(s) of Monetary Support

Postgraduate Research Fund, Universiti Malaya

Ethics review

Status: Approved
Approval date:
Contact:

University of Malaya Research Ethics (UMREC)